ACTRIS – scenario 1, temperature excursion

The site monitor, during an on-site visit flags a temperature excursion has occurred the past week. This has not been reported yet to the team, and next week already, the IMP from that particular refrigerator needs to be dispensed to a newly enrolled trial participant.

After having collected the necessary information*, a new issue is created in ACTRIS, set to priority ‘high’ and to risk type ‘Project Risk – IMP/IP’, and assigned to the team member most knowledgeable and/or available**. A picture of the temperature graph is appended, alongside the telephone number of the local site Pharmacy representative. The site monitor next can resume his/her other work whilst visiting this site, and wait for feedback on the ACTRIS issue’s ‘comment’ field. Jira’s app can be used to keep an eye on the team’s feedback.

If advise is needed from a member outside of the team (with no access to ACTRIS), a PDF can be made within three mouse clicks, and this can be forwarded via e-mail.

In the Site Monitoring Report, this particular issue flagged is reported by using the hyperlink to its ACTRIS issue. This way, action items will be kept separate, yet integrated (eventually), avoiding duplication of efforts. Follow-up to the issue will be given to the issue itself, within the timelines specified for ‘high’ priority risks. There is no need to use e-mail when it gets to informing all in the team. The report reviewer will have a timely view on the issue at the moment of review***, by clicking on the link.

*to allow for a Root Cause Analysis

**a solution to team members working across time zones, and regions

***usually, the reviewer is the PM, who can add final comments to the issue, and next resolve and close it. Only the PM can close out issues, as per authorization level set on ACTRIS

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